Kornimate/medical-research-clean huggingface dataset:
randomized, controlled trial of an intervention for preschool children with autism: teacch

Conditions: Autism Spectrum Disorder

Summary: this study is design to evaluate the efficacy of the treatment and education of autistic and communication handicapped children (teacch) on the rehabilitation for preschool children with autism spectrum disorders (asd) in china.a case-randomized controlled study was conducted.sixty children diagnosed with asd between 36 and 90 months of age were randomly assigned to the a teacch intervention group or a control group.the control group was subjected to regular rehabilitation training, the teacch group carried out teacch training besides regular rehabilitation training for 6 months. chinese version of psycho-educational profile-3rd edition (cpep-3) was used to evaluate the effectiveness of teacch rehabilitation training.

statistical analysis plan:the results were analyze using descriptive, t-test and anova.

Eligibility criteria:
inclusion criteria: * diagnosed by two children's psychiatrists above the level of the attending physician, in accordance with the diagnostic criteria of dsm-v (diagnostic and statistical manual of mental disorder, fifth revised) children's autism spectrum disorder issued by the united states in 2013. diagnostic screening scales include autism behavior checklist (abc), childhood autism rating scale (cars), and modified checklist for autism in toddlers (m-chat) (for under 4 years old), social communication questionnaire (scq) (for over 4 years old), all children' scores above the scale suggest asd performance; * able to cooperate with clinical evaluation and related examinations, and the guardian signs the informed consent to agree to participate in the study. exclusion criteria: * combined with other mental illnesses such as adhd, with major physical and nervous system diseases; * serious self-harm.

Keywords: teacch
safety and efficacy study of ivb102 injection in subjects with x-linked retinoschisis

Conditions: Retinoschisis; Retinal Disease; Retinal Degeneration; Eye Diseases

Summary: the goal of this clinical trial is to evaluate the safety and efficacy of ivb102 injection in subjects with xlrs.

this is a open label, dose escalation, single-center study. one eye of each participant will receive a single ivb102 injection by intravitreal injection. participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.

Eligibility criteria:
inclusion criteria: 1. must be willing and able to provide written, signed informed consent. 2. male individual at least 8 years of age with clinical diagnosis of xlrs caused by mutations in rs1. 3. best corrected visual acuity (bcva) in the study eye of less than or equal to 63 (corresponding to a snellen acuity of 20/63). 4. must agree to use effective barrier (male or female condom) of contraception before dosing and continuing one year after gene transfer. exclusion criteria: 1. lens, cornea, or other media opacities in the study eye that preclude adequate visualization and testing of the retina. 2. pre-existing eye conditions that would contribute significantly to visual loss or increase the risk of an intravitreal injection (e.g. dr、rvo or large retinal detachment). 3. any intraocular surgery in the study eye within 6 months prior to screening. 4. use of topical carbonic anhydrase inhibitors within 3 months prior to screening. 5. use of anticoagulants or anti-platelet agents within 7 days prior to study agent administration. 6. prior receipt of any aav gene therapy product. 7. use of any investigational agent within 3 months prior to screening.
gastric- versus jejunal feeding tubes in alcoholic liver diseases

Conditions: Malnutrition; Liver Diseases, Alcoholic

Summary: the study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake. the primary outcome will be differences in nutrition intake between the groups. secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea \& vomiting. the study will include 40 patients at aarhus university hospital, denmark.


Eligibility criteria:
inclusion criteria: * alcoholic liver disease * nutrition intake less than 75% of needed intake * signed informed consent form exclusion criteria: * hepatic encephalopathy, grade 3 - 4 * anatomic barriers to have a tube placed
high-intensity interval training and telerehabilitation

Conditions: Coronary Artery Disease

Summary: telerehabilitation has the potential to become an alternative attitude to outpatient cardiac rehabilitation. the aim of our study is to research the method of high-intensity interval training in the home environment using telerehabilitation. investigators assume that the high-intensity interval training form of telerehabilitation, using a heart rate monitor as a tool for backing up training data, can improve physical fitness and lead to higher peak oxygen uptake as the traditional moderate-intensity continuous training. the study is designed as a monocentral randomized controlled trial at university hospital brno in the czech republic. after the coronary event, eligible patients will be randomly (in 1:1 ratio) separated into two groups: the experimental high-intensity interval training group and the moderate-intensity continuous control group. both groups undergo a 12-week telerehabilitation training program with a 52-week follow-up period. the primary outcome observed will be the effect of intervention expressed by changes in peak oxygen uptake values.

the study relates to the previous study project cr-gps, in which investigators proved the feasibility of cardiac telerehabilitation. the results showed that aerobic capacity and quality of life improved similarly in telerehabilitation and outpatient group of participating patients. during the research, investigators used the moderate-intensity continuous method. the present research focuses on high-intensity interval training, which presents comparable or even better results in cardiorespiratory condition effects and requires less time than a continuous method in patients with low or medium cardiovascular risk.

Eligibility criteria:
inclusion criteria: * participants with coronary artery disease (in last two months) * with low or medium cardiovascular risk * with heart revascularization * with recommended pharmacotherapy * with clinically stable state * with the ability to perform a cardiopulmonary exercise test * with the ability to understand and write in the czech language * with an internet connection at home * literacy with information and communication technology exclusion criteria: * participants who were hospitalized with heart disease in the previous six weeks * with psychological severe or cognitive disorders * with contraindications for cardiopulmonary exercise testing * with severe training limitations besides coronary artery disease * with a planned intervention or operation * participants who are enrolled in or participate in an outpatient form of cardiac rehabilitation * participants who plan to be or are included in other studies

Keywords: cardiac rehabilitatiion telerehabilitation high-intensity interval training cardiorespiratory fitness
solid tumor cancer surgery with or without intraoperative imaging: a registry

Conditions: Bladder Cancer; Gastric Cancer

Summary: the study objective is to collect prospective data on cancer patients who undergo surgery and intraoperative imaging. the registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. the registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance. in this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. also, we will monitor any side effects or potential toxicities that may occur. this data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Eligibility criteria:
inclusion criteria: * adult patients \>/= 18 years of age. * patients presenting with esophagogastric or bladder cancer. * good operative candidate as determined by the treating physician and/or multidisciplinary team. * subject capable of giving informed consent and participating in the process of consent. exclusion criteria: * pregnant women as determined by urinary or serum beta hcg within 72 hours of surgery. * vulnerable patient population.
the acute cardiovascular effects of marathon running using magnetic resonance imaging

Conditions: Myocardial Ischemia; Left Ventricular Systolic Dysfunction; Elevated Cardiac Enzymes

Summary: using blood testing and cardiac magnetic resonance imaging (mri), the investigators aim to determine if there are necrotic areas of myocardium in participants who complete a marathon. in addition, the investigators aim to describe the acute and chronic structural abnormalities that occur as a result of endurance training. the study hypothesis is that myocardial necrosis is present in runners completing a marathon competition.

marathon-mi is a prospective, observational study of twenty-five (25) participants with plans of completing the detroit free press marathon in detroit, michigan on october 19, 2008. all participants will undergo a rigorous pre-marathon screening process which will include: 1) blood testing, 2) complete cardiopulmonary exercise testing, 3) ecg testing, 4) holter monitoring, 5) cardiac mri. blood work will be check after the marathon immediately after and one day after the event. cardiac mri will be repeated within 12 hours of finishing the marathon. using the information derived from the blood work and radiological testing, we will attempt to determine if there is an association between marathon running and myocardial necrosis.

Eligibility criteria:
inclusion criteria: * detroit free press marathon participant on october 19, 2008, * age \> 18 years old, * ability to provide informed consent. exclusion criteria: * known coronary or structural heart disease * pregnancy, * extreme claustrophobia, * metal implants, * renal dysfunction.

Keywords: marathon running cardiac ischemia magnetic resonance imaging
anterior cruciate ligament rupture

Conditions: Anterior Cruciate Ligament Rupture

Summary: the assess results of anterior cruciate ligament (acl) repair with the ligamys® surgical technique versus standard technique. the aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

the treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique. contrary to the classic ligamentoplasty, the treatment with ligamys consists of promoting heating of the ligament itself by controlling mechanical environment. it allows a "dynamic" stabilization of the torn anterior cruciate ligament with in the 3 weekly following traumatism. these techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. it's all these issues we would like to assess with a randomised multicenter study.

Eligibility criteria:
inclusion criteria: * age between 18 to 35 years * primary anterior cruciate ligament rupture * signed patient consent * surgery 21 days or less after traumatism for ligamys technique exclusion criteria: * infection of the operating site * previous osseous disease * pregnant or nursing woman.

Keywords: rupture anterior cruciate ligament (acl) laxity knee instability knee
long-term comparison of fixed- and mobile-bearing total knee arthroplasties (tkas) in patients with oa ≤50 years old

Conditions: Osteoarthritis

Summary: the purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare 1. functional scores 2. rates of radiographic failure 3. revision rates 4. survivorship

the randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. the purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.

Eligibility criteria:
inclusion criteria: * end-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease exclusion criteria: * inflammatory disease * patient with other lower extremity disease which may affect functional outcome * neurologic disease effecting patients lower extremity * revision surgery * patient not medically cleared for bilateral surgery

Keywords: total knee arthroplasty fixed-bearing mobile-bearing long-term
statins, cholesterol and cognitive decline in alzheimer's

Conditions: Alzheimer Dementia; Statins

Summary: disturbances in brain cholesterol homeostasis may be involved in the pathogenesis of alzheimer's disease (ad). lipid-lowering medications could interfere with neurodegenerative processes in ad through cholesterol metabolism or other mechanisms. the investigators aim to estimate the causal effect of statins on cognitive function measured by mmse and to identify the mediating or modifying effect of cholesterol between statins and cognitive function in patients with alzheimer's disease.


Eligibility criteria:
inclusion criteria: all patients with ad and mixed dementia registered in svedem and from scream. exclusion criteria: * all patients with a missing mmse score at diagnosis date will be excluded from the analyses. * patients with at least one measurement of low-density lipoprotein cholesterol (ldl-c) within 1 year before dementia diagnosis.
management of patients with chronic obstructive pulmonary disease in granada: a clinical audit

Conditions: COPD

Summary: it is actually unknown how are the copd clinical guidelines followed in primary care in andalusia, specially for diagnosis and follow up of patients with this diseases. detection of areas for improvement in copd healthcare can be useful in order to implement improvement programs. this project is a clinical audit among primary care centres in granada attending patients with copd in the public health system

the aim of this study is to audit the attention to people with copd among primary care centres in granada, as well as how clinical guidelines are followed and other recommendations. the study will comprise medical records from more than 3000 patients.

Eligibility criteria:
inclusion criteria: * adults (men or women) aged more than 40 years old * diagnostic code in andalusian clinical records (diraya) in accordance with icd-9 (diagnostic codes 496, 492.8, 494.0, 491.20, 493.2) * current of former smokers of at least 10 pack- years * patient with a minimum follow up of 1 year, who have been assisted in a scheduled primary care appointment at inclusion date. exclusion criteria: * patients with a diagnostic code for copd attended at primary care office, but without information related with copd in the previous year. * patients currently involved in any clinical trial or research study related with copd. * those patients excluded will be collected in an exclusion causes chart for each centre. these patients will not affect overall number of patients targeted for each centre.

Keywords: copd emphysema chronic bronchitis clinical audit primary healthcare
lidocaine, esmolol, or placebo to relieve iv propofol pain

Conditions: Injection Site Irritation; Pain

Summary: the primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool

the study will include three arms: lidocaine, esmolol, and placebo. eligible patients will be 18-60 years old, asa physical status 1-3, and scheduled for an elective surgical procedure. patients will be randomized to receive lidocaine, esmolol, or placebo. both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered

Eligibility criteria:
inclusion criteria: * 18-60 years of age * asa 1-3 * elective surgical procedure exclusion criteria: * bmi ≥ 45 * pregnancy * requirement for rsi or awake intubation * suspected or known difficult airway * contraindication to iv in either upper extremity * chronic pain syndrome including fibromyalgia * use of opioids, nsaids, or other analgesics within 24 hours (including preoperative po celebrex, lyrica, tylenol, etc.) * any use of opioids in the past three months * significant cardiopulmonary or hepatic dysfunction * hypersensitivity to study medications
isolation, characterization and evaluation of the potential of tissue-resident cells from waste musculoskeletal and associated connective tissues

Conditions: Musculoskeletal Diseases

Summary: the general purpose of this study is characterization of tissue-resident cells derived from different musculoskeletal and/or associated connective tissues (such as cartilage, synovial membrane, synovial fluid, bone, adipose tissue and tendons), in order to identify new strategies for the treatment of degenerative and inflammatory musculoskeletal disorders. cells isolated from different tissue sources will be compared with each other by phenotypic and functional characterization, following culture and treatment with inflammatory elements, drugs and orthobiologics. moreover, with the aim to assess predictive markers of therapeutic success, a correlation study of the content and properties of the cells isolated from different types of tissue with the clinical profile of the enrolled patients will be conducted.


Eligibility criteria:
inclusion criteria: * males and females * 18 years old * patients undergoing elective surgery at irccs istituto ortopedico galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (acl) reconstruction or rotator cuff repair exclusion criteria: * age \< 18 years old * patients unable to sign the informed consent * positivity to virological test (hiv, hcv, hbv, tpha)
study of nms-1116354 in advanced/metastatic solid tumors

Conditions: Advanced/Metastatic Solid Tumors

Summary: the purpose of this study is to evaluate the safety profile of nms-1116354, a cdc7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.


Eligibility criteria:
inclusion criteria: 1. advanced/metastatic solid tumors, for which no alternative effective standard therapy is available 2. maximum of 4 regimens of prior cancer therapy allowed 3. prior radiotherapy allowed if no more than 25% of bm reserve irradiated 4. resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy 5. ecog performance status (ps) 0 or 1 6. adult (age \>/= 18 and \</= 80 years) patients 7. adequate renal, liver and bm reserve 8. capability to swallow capsules intact exclusion criteria: 1. current enrollment in another therapeutic clinical trial 2. known brain metastases 3. currently active second malignancy 4. major surgery within 4 weeks prior to treatment 5. any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis 6. pregnancy or breast-feeding women 7. known active infections 8. gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption 9. adrenal insufficiency 10. other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives

Keywords: phase i study advanced/metastatic solid tumors cdc7 kinase inhibitor
amifostine in treating patients with cancer who have neurological changes caused by chemotherapy

Conditions: Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. purpose: phase iv trial to study the effectiveness of amifostine in treating patients with cancer who have neurological changes caused by chemotherapy.

objectives: i. determine the feasibility and tolerability of administering amifostine by intravenous infusion over 5 minutes in cancer patients undergoing chemotherapy. outline: this is an open label, controlled study. patients receive intravenous amifostine over 5 minutes 30 minutes prior to chemotherapy. patients are followed for one month post treatment. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically proven cancer no brain or other cns metastases (including prior treated metastases) patient characteristics: age: 18 and over performance status: ecog 0-1 life expectancy: not specified hematopoietic: not specified hepatic: no grade 3 or greater hepatic dysfunction renal: no hypercalcemia cardiovascular: no uncontrolled hypotension other: not pregnant or nursing effective contraceptive method must be used by fertile patients no psychosis no severe concurrent illness other than neoplasia no epileptic seizures during the previous year, migraines, gastrointestinal obstructions, or other causes of vomiting no prior or concurrent amifostine contraindications no prior known contraindications or sensitivity to dexamethasone, granisetron, ondansetron, prochlorperazine, diphenhydramine, cimetidine, or magnesium prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: no prior estrogen within 24 hours of amifostine therapy radiotherapy: not specified surgery: not specified other: no prior alcohol, disulphiram, tetracycline, or erythromycin within 24 hours of amifostine therapy no prior antiemetics such as benzodiazepines, antipsychotics, anticonvulsants, or antihistamines within 24 hours of amifostine therapy

Keywords: unspecified adult solid tumor, protocol specific drug/agent toxicity by tissue/organ
cognitive behavioral therapy (cbt)-insomnia for lung cancer

Conditions: Chronic Insomnia

Summary: the purpose of this study is to determine whether cognitive behavioral therapy (cbt) is effective for insomnia in lung cancer survivors.

a randomized controlled clinical trial will be used to test the efficacy of this brief cbt-i compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based cbt-i into the clinical setting.

Eligibility criteria:
inclusion criteria: * 6 weeks from surgery for stage 1 or 2 non small cell lung cancer * chronic insomnia exclusion criteria: * other preexisting sleep disorders * unstable medical illnesses

Keywords: lung cancer survivors insomnia treatment cognitive behavioral therapy